MedPath

Survey on Long-Term Use of BI-Sifrol® Tablets in Patients With Restless Legs Syndrome

Completed
Conditions
Restless Legs Syndrome
Registration Number
NCT01174459
Lead Sponsor
Boehringer Ingelheim
Brief Summary

The survey is conducted to investigate the safety and efficacy of long-term use of BI-Sifrol Tablets in Restless Legs Syndrome (RLS) patients with or without renal dysfunction in routine medical practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
571
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Incidence of Drug-related Adverse Events12 Months

Number of patients with drug-related adverse events

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Total Score of the International Restless Legs Syndrome Rating Scale (IRLS)after 12 months or at the end of observation

International Restless Legs Syndrome rating scale (IRLS): The IRLS rating scale is a selfrating scale used to evaluate the severity of RLS and the patients are requested to answer 10 questions on a scale of 0 to 4. Respective scores (0-4 points) for the 10 questions were added up to calculate the total score on the IRLS. Therefore the total score is 0-40. The lower values represent a better outcome.

Trial Locations

Locations (159)

Boehringer Ingelheim Investigational Site 94

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Toyokawa, Japan

Boehringer Ingelheim Investigational Site 151

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Kumamoto, Japan

Boehringer Ingelheim Investigational Site 82

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Gifu, Japan

Boehringer Ingelheim Investigational Site 1

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Asahikawa, Japan

Boehringer Ingelheim Investigational Site 123

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Himeji, Japan

Boehringer Ingelheim Investigational Site 60

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Kawasaki, Japan

Boehringer Ingelheim Investigational Site 143

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Kurume, Japan

Boehringer Ingelheim Investigational Site 7

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Fukagawa, Japan

Boehringer Ingelheim Investigational Site 108

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Sakai, Japan

Boehringer Ingelheim Investigational Site 14

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Sendai, Japan

Boehringer Ingelheim Investigational Site 45

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Tokyo Meguro, Japan

Boehringer Ingelheim Investigational Site 72

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Toyama, Japan

Boehringer Ingelheim Investigational Site 144

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Fukuoka, Japan

Boehringer Ingelheim Investigational Site 36

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Asahi, Japan

Boehringer Ingelheim Investigational Site 158

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Chofu, Japan

Boehringer Ingelheim Investigational Site 78

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Chuo, Japan

Boehringer Ingelheim Investigational Site 66

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Fujisawa, Japan

Boehringer Ingelheim Investigational Site 146

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Fukuoka, Japan

Boehringer Ingelheim Investigational Site 92

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Nagoya, Japan

Boehringer Ingelheim Investigational Site 97

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Otsu, Japan

Boehringer Ingelheim Investigational Site 42

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Tokyo Arakawa, Japan

Boehringer Ingelheim Investigational Site 54

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Tokyo Minato, Japan

Boehringer Ingelheim Investigational Site 116

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Toyonaka, Japan

Boehringer Ingelheim Investigational Site 102

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Kyoto, Japan

Boehringer Ingelheim Investigational Site 85

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Nagoya, Japan

Boehringer Ingelheim Investigational Site 13

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Morioka, Japan

Boehringer Ingelheim Investigational Site 134

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Miyoshi, Japan

Boehringer Ingelheim Investigational Site 2

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Muroran, Japan

Boehringer Ingelheim Investigational Site 87

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Nagoya, Japan

Boehringer Ingelheim Investigational Site 11

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Ninohe, Japan

Boehringer Ingelheim Investigational Site 121

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Nishinomiya, Japan

Boehringer Ingelheim Investigational Site 17

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Odate, Japan

Boehringer Ingelheim Investigational Site 105

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Osaka, Japan

Boehringer Ingelheim Investigational Site 39

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Sakura, Japan

Boehringer Ingelheim Investigational Site 5

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 6

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 8

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 27

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Shimotsuke, Japan

Boehringer Ingelheim Investigational Site 49

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Tokyo Nerima, Japan

Boehringer Ingelheim Investigational Site 3

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 15

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Sendai, Japan

Boehringer Ingelheim Investigational Site 29

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Shimotsuke, Japan

Boehringer Ingelheim Investigational Site 109

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Takatsuki, Japan

Boehringer Ingelheim Investigational Site 12

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Takizawa-mura, Japan

Boehringer Ingelheim Investigational Site 84

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Shizuoka, Japan

Boehringer Ingelheim Investigational Site 110

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Takatsuki, Japan

Boehringer Ingelheim Investigational Site 91

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Toyokawa, Japan

Boehringer Ingelheim Investigational Site 159

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Yokose-machi, Japan

Boehringer Ingelheim Investigational Site 133

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Hiroshima, Japan

Boehringer Ingelheim Investigational Site 50

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Kodaira, Japan

Boehringer Ingelheim Investigational Site 22

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Ami-machi, Japan

Boehringer Ingelheim Investigational Site 115

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Minoo, Japan

Boehringer Ingelheim Investigational Site 20

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Tsuchiura, Japan

Boehringer Ingelheim Investigational Site 35

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Tsurugashima, Japan

Boehringer Ingelheim Investigational Site 77

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Tsuruga, Japan

Boehringer Ingelheim Investigational Site 28

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Mibu-machi, Japan

Boehringer Ingelheim Investigational Site 67

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Yokohama, Japan

Boehringer Ingelheim Investigational Site 24

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Tsukuba, Japan

Boehringer Ingelheim Investigational Site 156

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Urazoe, Japan

Boehringer Ingelheim Investigational Site 23

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Ushiku, Japan

Boehringer Ingelheim Investigational Site 25

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Ushiku, Japan

Boehringer Ingelheim Investigational Site 135

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Yanai, Japan

Boehringer Ingelheim Investigational Site 18

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Yamagata, Japan

Boehringer Ingelheim Investigational Site 61

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Yokohama, Japan

Boehringer Ingelheim Investigational Site 62

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Yokohama, Japan

Boehringer Ingelheim Investigational Site 75

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Utinada-machi, Japan

Boehringer Ingelheim Investigational Site 59

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Yokohama, Japan

Boehringer Ingelheim Investigational Site 65

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Yokohama, Japan

Boehringer Ingelheim Investigational Site 136

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Yoshinogawa, Japan

Boehringer Ingelheim Investigational Site 155

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Kagoshima, Japan

Boehringer Ingelheim Investigational Site 119

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Akashi, Japan

Boehringer Ingelheim Investigational Site 52

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Akishima, Japan

Boehringer Ingelheim Investigational Site 16

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Akita, Japan

Boehringer Ingelheim Investigational Site 40

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Chiba, Japan

Boehringer Ingelheim Investigational Site 19

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Fukushima, Japan

Boehringer Ingelheim Investigational Site 132

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Fukuyama, Japan

Boehringer Ingelheim Investigational Site 83

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Hamamatsu, Japan

Boehringer Ingelheim Investigational Site 56

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Hatchioji, Japan

Boehringer Ingelheim Investigational Site 129

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Hayashima-machi, Japan

Boehringer Ingelheim Investigational Site 111

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Hirakata, Japan

Boehringer Ingelheim Investigational Site 30

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Honjo, Japan

Boehringer Ingelheim Investigational Site 38

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Ichihara, Japan

Boehringer Ingelheim Investigational Site 79

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Ichikawasango-machi, Japan

Boehringer Ingelheim Investigational Site 37

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Ichikawa, Japan

Boehringer Ingelheim Investigational Site 117

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Ikeda, Japan

Boehringer Ingelheim Investigational Site 149

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Isahaya, Japan

Boehringer Ingelheim Investigational Site 118

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Itami, Japan

Boehringer Ingelheim Investigational Site 10

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Iwamizawa, Japan

Boehringer Ingelheim Investigational Site 127

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Izumo, Japan

Boehringer Ingelheim Investigational Site 154

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Kagoshima, Japan

Boehringer Ingelheim Investigational Site 74

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Kanazawa, Japan

Boehringer Ingelheim Investigational Site 120

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Katou, Japan

Boehringer Ingelheim Investigational Site 124

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Kawai-machi, Japan

Boehringer Ingelheim Investigational Site 76

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Kanazawa, Japan

Boehringer Ingelheim Investigational Site 63

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Kawasaki, Japan

Boehringer Ingelheim Investigational Site 31

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Keroyama-machi, Japan

Boehringer Ingelheim Investigational Site 145

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Kitakyuushu, Japan

Boehringer Ingelheim Investigational Site 122

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Kobe, Japan

Boehringer Ingelheim Investigational Site 46

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Kodaira, Japan

Boehringer Ingelheim Investigational Site 32

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Koshigaya, Japan

Boehringer Ingelheim Investigational Site 150

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Kumamoto, Japan

Boehringer Ingelheim Investigational Site 103

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Kyoto, Japan

Boehringer Ingelheim Investigational Site 98

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Kyoto, Japan

Boehringer Ingelheim Investigational Site 99

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Kyoto, Japan

Boehringer Ingelheim Investigational Site 100

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Maizuru, Japan

Boehringer Ingelheim Investigational Site 142

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Mat?uyama, Japan

Boehringer Ingelheim Investigational Site 80

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Matsumoto, Japan

Boehringer Ingelheim Investigational Site 81

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Matsumoto, Japan

Boehringer Ingelheim Investigational Site 47

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Mitaka, Japan

Boehringer Ingelheim Investigational Site 153

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Miyazaki, Japan

Boehringer Ingelheim Investigational Site 138

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Miki-machi, Japan

Boehringer Ingelheim Investigational Site 112

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Moriguchi, Japan

Boehringer Ingelheim Investigational Site 88

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Nagakute-machi, Japan

Boehringer Ingelheim Investigational Site 101

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Nagaokakyo, Japan

Boehringer Ingelheim Investigational Site 41

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Nagareyama, Japan

Boehringer Ingelheim Investigational Site 148

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Nagasaki, Japan

Boehringer Ingelheim Investigational Site 86

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Nagoya, Japan

Boehringer Ingelheim Investigational Site 68

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Nigata, Japan

Boehringer Ingelheim Investigational Site 69

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Nigata, Japan

Boehringer Ingelheim Investigational Site 70

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Nigata, Japan

Boehringer Ingelheim Investigational Site 71

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Nigata, Japan

Boehringer Ingelheim Investigational Site 139

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Niihama, Japan

Boehringer Ingelheim Investigational Site 141

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Niihama, Japan

Boehringer Ingelheim Investigational Site 157

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Nishitokyo, Japan

Boehringer Ingelheim Investigational Site 152

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Oita, Japan

Boehringer Ingelheim Investigational Site 130

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Okayama, Japan

Boehringer Ingelheim Investigational Site 131

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Okayama, Japan

Boehringer Ingelheim Investigational Site 104

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Osaka, Japan

Boehringer Ingelheim Investigational Site 113

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Osakasayama, Japan

Boehringer Ingelheim Investigational Site 89

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Okazaki, Japan

Boehringer Ingelheim Investigational Site 106

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Osaka, Japan

Boehringer Ingelheim Investigational Site 128

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Ota, Japan

Boehringer Ingelheim Investigational Site 140

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Ozu, Japan

Boehringer Ingelheim Investigational Site 64

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Sagamihara, Japan

Boehringer Ingelheim Investigational Site 26

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Ryugasaki, Japan

Boehringer Ingelheim Investigational Site 147

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Saga, Japan

Boehringer Ingelheim Investigational Site 34

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Saitama, Japan

Boehringer Ingelheim Investigational Site 107

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Sakai, Japan

Boehringer Ingelheim Investigational Site 4

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 9

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Sapporo, Japan

Boehringer Ingelheim Investigational Site 125

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Shingu, Japan

Boehringer Ingelheim Investigational Site 95

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Suzuka, Japan

Boehringer Ingelheim Investigational Site 96

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Suzuka, Japan

Boehringer Ingelheim Investigational Site 137

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Takamatsu, Japan

Boehringer Ingelheim Investigational Site 33

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Tokorozawa, Japan

Boehringer Ingelheim Investigational Site 53

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Tokyo Chuo, Japan

Boehringer Ingelheim Investigational Site 43

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Tokyo Itabashi, Japan

Boehringer Ingelheim Investigational Site 55

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Tokyo Nerima, Japan

Boehringer Ingelheim Investigational Site 44

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Tokyo Ota, Japan

Boehringer Ingelheim Investigational Site 51

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Tokyo Shibuya, Japan

Boehringer Ingelheim Investigational Site 58

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Tokyo Shibuya, Japan

Boehringer Ingelheim Investigational Site 57

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Tokyo Shinagawa, Japan

Boehringer Ingelheim Investigational Site 48

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Tokyo Shinjyuku, Japan

Boehringer Ingelheim Investigational Site 126

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Tottori, Japan

Boehringer Ingelheim Investigational Site 21

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Toride, Japan

Boehringer Ingelheim Investigational Site 73

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Toyama, Japan

Boehringer Ingelheim Investigational Site 90

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Toyohashi, Japan

Boehringer Ingelheim Investigational Site 93

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Toyohashi, Japan

Boehringer Ingelheim Investigational Site 114

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Toyonaka, Japan

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